MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® FN PLUS; BACT/ALERT FN PLUS (PLASTIC)

Catalog Number 410852

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: bact/alert® fn plus culture bottles are used with bact/alert® microbial detection systems in qualitative procedures for the recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids.Issue description: a customer in the united states notified biomérieux of false positive results (potential contamination) in association with bact/alert fn plus (plastic) (ref.(b)(4), batch number unknown) with a patient sample.Customer reported that vacutainer tube was not transferring blood to anaerobic (fn plus) bottles, and that this was happening only with anaerobic bottles.Customer said that the issue stopped after they began using a new lot of bottles, but they discarded the box that had the problematic bottles so they don't know what lot number they were.It was reported that the customer believes that one bottle was considered as positive due to contamination while drawing from the vacutainer with a syringe.According to biomérieux local customer service, it assumed that the bottle was called positive due to contamination from the syringe draw, but this is not confirmed.At the time of assessment, there is no indication or report from the customer that the false positive results led to any adverse event related to any patient's state of health.At the time of the global assessment, the cause of the contamination/the false positive result has not been confirmed.An investigation will be initiated.

Manufacturer Narrative

Context: a customer in the united states notified biomérieux of false positive results (potential contamination) in association with bact/alert fn plus (plastic) (ref.(b)(4), batch number unknown) with a patient sample.The complaint under investigation stemmed from a bottle inoculation vacuum event that led the customer to drawing blood cultures using the syringe draw inoculation method for blood culture collection.The bottle vacuum issue resolved itself after the customer started to use a new bottle lot of bact/alert® fn plus bottles.There was insufficient and limited data provided; the lot number is unknown, and the identification of the organism was not provided.Investigation: batch history record and complaint trend analysis.There is no capa related to the customer¿s complaint recorded.The trend analysis has been performed and has shown no out-of-control trend present for the catalog profile bact/alert reagent clinical use b18 and the error code bottle contamination inoculated - b103 for the period from 09-jun-2022 to 20-oct-2023.Investigation results.The bottle was tested on the bact/alert® 3d combination module with serial number (b)(6) installed 29jul2002.There was insufficient information provided from the customer for example patient details, bottle id, no reagent lot number was provided, if there were mate bottle collected and the results, specific time to detections, collection locations and the customer did not specify which organism was recovered as a contaminant versus a true positive.The customer did not take internal action to attempt to find the source of the organism contamination.There were no instrument backup or graph provided by the customer for global customer service to evaluate.There was no indication or report from the laboratory that the probable contaminant result led to any adverse event related to any patient¿s state of health.The customer did not report finding any bottles that looked to be contaminated before use or any bottles with any visual defects.Due to the lack of detailed information from the customer, the investigator was only able to perform a root cause analysis on the possible contributors to the presence of contamination in bact/alert bottles.The five whys root cause analysis tool was used with the known characteristics of the bact/alert® fn plus culture bottle type.Root cause analysis and conclusion.The investigator used the five whys root cause analysis tool.Due to the lack of detailed information from the customer, the investigator was only able to perform a root cause analysis on the possible contributors to the presence of contamination.The five whys root cause analysis tool was used with the known characteristics of the bact/alert fn plus culture bottle type.The most probable root cause is the user.The user controls all of the conditions: unable to differentiate between a contaminant and a true pathogen, collection of blood cultures related to skin antisepsis and the methods of obtaining blood for culture, and not disinfecting the bottle tops.The investigator was unable to investigate due to lack of information, therefore the root cause is not able to be determined, only a probable root cause was identified.Queries of the manufacturing data, and the complaint data do not reveal any adverse trend for any issue related to contamination.Since the lot was not provided, review of the manufacturing records for bact/alert® fn plus culture bottle could not be performed.However, all lots released to the field met all quality control and release criteria.Monitoring and detection methods for potential bottle contamination are part of the manufacturing and quality control processes for bact/alert culture bottles.The bottle instructions for use (ifu) were reviewed by the investigator and found to have adequate directions for the user.Great care must be taken to prevent contamination of the patient sample during venipuncture and during inoculation into the culture bottle since contamination could lead to a specimen being determined positive when a clinically relevant isolate is not actually present.It is important to disinfect the bottle top using one disinfectant wipe per bottle and to follow the disinfectant manufacturer directions for drying time.Conclusion: the customer identified the positive result as a contaminant that occurred from the customer¿s blood culture collection technique of using the syringe draw inoculation method.Manufacturing processes for bact/alert culture bottles expose the bottles to higher temperatures than most organism growth temperatures during the terminal autoclave step.Monitoring of environmental parameters occurs for manufacturing rooms and all bact/alert culture bottle release records.In addition, by the time the customer receives their bottle shipment, the bottles are usually older than one to two months.Any manufacturing contaminant would have grown in the nutritious broth, making the broth turbid and the sensor yellow; thus, easily detectable before use.There is no evidence of any bottle malfunction with the bact/alert® fn plus culture bottle type.Monitoring and detection methods for potential bottle contamination are part of the manufacturing and quality control processes for bact/alert culture bottles.No further action required.

• Brand Name: BACT/ALERT® FN PLUS
• Type of Device: BACT/ALERT FN PLUS (PLASTIC)
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• Manufacturer (Section G): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• Manufacturer Contact: céline strauel ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 17169997
• MDR Text Key: 317544971
• Report Number: 3002769706-2023-00020
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026357917
• UDI-Public: 03573026357917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 410852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1